Comparative Study of Dissolution for Cannabidiol in EU and US Hemp Oil Products by HPLC

Analakkattillam, Sandhyarani; Langsi, Victor K.; Hanrahan, John P.; Moore, Eric

doi:10.1016/j.xphs.2021.03.028

Cited by 6 publications

(4 citation statements)

References 21 publications

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“…The last is used to mimic the transdermal environment, whilst SGF and SIF mimic oral administration and the gastrointestinal environment, respectively. As expected, pure CBD has a low solubility profile in both SIF and SGF, with less than 10% of CBD released in 48 h. These values are consistent with the solubility profile of CBD oil found by others [ 30 ]. In SSW, the solubility profile remains low in the first 24 h, but a jump is observed thereafter, with a total release in 48 h approximating 50% of the dose added.…”

Section: Resultssupporting

confidence: 91%

Enhanced Skin Penetration of Cannabidiol Using Organosilane Particles as Transdermal Delivery Vehicles

et al. 2023

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There is potential for cannabidiol to act as an analgesic, anxiolytic and antipsychotic active ingredient; however, there is a need to find alternate administration routes to overcome its low oral bioavailability. In this work, we propose a new delivery vehicle based on encapsulation of cannabidiol within organosilica particles as drug delivery vehicles, which are subsequently incorporated within polyvinyl alcohol films. We investigated the long-term stability of the encapsulated cannabidiol, as well as its release rate, in a range of simulated fluids with different characterization techniques, including Fourier Transform Infrared (FT-IR) and High-performance Liquid Chromatography (HPLC). Finally, we determined the transdermal penetration in an ex vivo skin model. Our results show that cannabidiol is stable for up to 14 weeks within polyvinyl alcohol films at a range of temperatures and humidity. Release profiles are first-order, consistent with a mechanism involving diffusion of the cannabidiol (CBD) out of the silica matrix. The silica particles do not penetrate beyond the stratum corneum in the skin. However, cannabidiol penetration is enhanced and is detected in the lower epidermis, which was 0.41% of the total CBD in a PVA formulation compared with 0.27% for pure CBD. This is partly due to an improvement of its solubility profile as it is released from the silica particles, but we cannot rule out effects of the polyvinyl alcohol. Our design opens a route for new membrane technologies for cannabidiol and other cannabinoid products, where administration via non-oral or pulmonary routes can lead to better outcomes for patient cohorts in a range of therapeutics.

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Section: Resultssupporting

confidence: 91%

Enhanced Skin Penetration of Cannabidiol Using Organosilane Particles as Transdermal Delivery Vehicles

et al. 2023

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“…Pure CBD has a low solubility profile in both SIF and SGF, with less than 3% within 1 h and less than 10% of CBD released in 48 h [ 106 ]. CBD-Silica cast in PVA films show a significantly increased dissolution profile of SIF and SGF, with about 3–7% of CBD released in 1 h and about 40–45% of released CBD in 48 h. Poor solubility of CBD from hemp oil products like oral drops, capsules, and tablets in an acidic medium was also confirmed as 0% of CBD released in FaSSGF, besides one beverage enhancer [ 107 ]. Koch et al [ 108 ] conducted a study on the dissolution properties of CBD formulations in a phosphate buffer with a pH of 6.8 and 0.5% sodium lauryl sulfate.…”

Section: Discussionmentioning

confidence: 99%

Co-Dispersion Delivery Systems with Solubilizing Carriers Improving the Solubility and Permeability of Cannabinoids (Cannabidiol, Cannabidiolic Acid, and Cannabichromene) from Cannabis sativa (Henola Variety) Inflorescences

Stasiłowicz-Krzemień,

Szulc,

Cielecka-Piontek

2023

Pharmaceutics

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Cannabinoids: cannabidiol (CBD), cannabidiolic acid (CBDA), and cannabichromene (CBC) are lipophilic compounds with limited water solubility, resulting in challenges related to their bioavailability and therapeutic efficacy upon oral administration. To overcome these limitations, we developed co-dispersion cannabinoid delivery systems with the biopolymer polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol (Soluplus) and magnesium aluminometasilicate (Neusilin US2) to improve solubility and permeability. Recognizing the potential therapeutic benefits arising from the entourage effect, we decided to work with an extract instead of isolated cannabinoids. Cannabis sativa inflorescences (Henola variety) with a confirming neuroprotective activity were subjected to dynamic supercritical CO2 (scCO2) extraction and next they were combined with carriers (1:1 mass ratio) to prepare the co-dispersion cannabinoid delivery systems (HiE). In vitro dissolution studies were conducted to evaluate the solubility of CBD, CBDA, and CBC in various media (pH 1.2, 6.8, fasted, and fed state simulated intestinal fluid). The HiE-Soluplus delivery systems consistently demonstrated the highest dissolution rate of cannabinoids. Additionally, HiE-Soluplus exhibited the highest permeability coefficients for cannabinoids in gastrointestinal tract conditions than it was during the permeability studies using model PAMPA GIT. All three cannabinoids exhibited promising blood-brain barrier (BBB) permeability (Papp higher than 4.0 × 10−6 cm/s), suggesting their potential to effectively cross into the central nervous system. The improved solubility and permeability of cannabinoids from the HiE-Soluplus delivery system hold promise for enhancement in their bioavailability.

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“…The proposed validated method was applied for the analysis of various hemp oil infused products and presented 40 . The samples tested were consist of tablets, capsules, tincture, oral drops, beverage-enhancers, and plant extract oils.…”

Section: Application Of Nal Methods To Hemp Oil Infusedmentioning

confidence: 99%

Analytical method validation for assay determination of cannabidiol and tetrahydrocannabinol in hemp oil infused products by RP-HPLC

Moore

Analakkattillam

Langsi

et al. 2022

Preprint

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A simple quantitative reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for assay determination of cannabidiol and tetrahydrocannabinol in hemp oil infused products. The RP-HPLC method was developed and optimized for the mobile phase composition, flow rate, column selection and detector wavelength. An isocratic elution of samples performed on SOLAS™ 100 Å C18 150 mm x 4.6 mm, 5 µm column with a mobile phase containing 75/25 acetonitrile/water v/v, delivered at a flow rate 1.5 mL/minutes to an Ultraviolet – Visible (UV/Vis) detector using 214 nm. The RP-HPLC method was validated to meet regulatory requirements and covers specificity, accuracy, range, linearity, precision, system suitability and robustness. The validated assay test method was applied successfully to quantify cannabidiol and tetrahydrocannabinol in commercial hemp oil infused products such as tablets, soft gel capsules, plant extract oils, oral drops, tincture, and beverage enhancers. All test results were found acceptable as per ICH guidelines, and this confirmed that the method is fit for its intended use in regular quality control and assay of cannabidiol and tetrahydrocannabinol in hemp oil infused products.

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Comparative Study of Dissolution for Cannabidiol in EU and US Hemp Oil Products by HPLC

Cited by 6 publications

References 21 publications

Enhanced Skin Penetration of Cannabidiol Using Organosilane Particles as Transdermal Delivery Vehicles

Enhanced Skin Penetration of Cannabidiol Using Organosilane Particles as Transdermal Delivery Vehicles

Co-Dispersion Delivery Systems with Solubilizing Carriers Improving the Solubility and Permeability of Cannabinoids (Cannabidiol, Cannabidiolic Acid, and Cannabichromene) from Cannabis sativa (Henola Variety) Inflorescences

Analytical method validation for assay determination of cannabidiol and tetrahydrocannabinol in hemp oil infused products by RP-HPLC

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